Chronic kidney disease is the modern-day plague in the United States, driven in large part by the nation's obesity epidemic. According to the National Kidney Foundation, 30 million Americans have chronic kidney disease, often due to diabetes and hypertension; that's 1 in 9 adults. More than 510,000 kidney patients are now on dialysis, and over 100,000 are on the kidney transplant list.
The cost of caring for these individuals is staggering. "Medicare alone spends $114 billion annually caring for Americans with all stages of chronic kidney disease, " said Kerry Willis, chief medical officer at the National Kidney Foundation. "That doesn't include the costs to the private insurance industry."
Recognizing the trend, an Israeli digital health start-up called Healthy.io has developed an FDA-cleared at-home smartphone urinalysis test to help people test their kidneys for proteins, a sign of damage to the organ. Early detection makes an enormous difference in avoiding complications from kidney disease.
Healthy.io's urinalysis test, Dip.io, uses disposable strips and cups in conjunction with a smartphone camera to read and interpret results. Patients dip a stick in a self-collected urine sample, wait for it to develop, and take a picture of it against a card using the company's app. The image is anonymized and put on the cloud for more detailed diagnostic tests.
The test has been assessed with Geisinger Health in conjunction with the National Kidney Foundation, achieving a 71 percent adherence rate among patients with hypertension who never have been tested before.
Founder and CEO Yonatan Adiri said that since Dip.io received FDA clearance last year, he has been busy marketing the technology to hospitals and health systems. The company is targeting a few major patient categories, including pregnant women, diabetics and hypertensives most at risk for kidney disease, and women who believe they may have the symptoms of UTI (urinary tract infection).
Adiri, the former chief technology officer to Israeli President Shimon Peres, developed a passion for health technology early in his career. He realized the smartphone as a medical tool was a niche that would grow when his father used it to transfer CT scans after his mother had an accident while traveling in China a few years ago. That helped her get diagnosed and saved her life.
"My goal is to help turn the mobile phone into the lab of today," he said. "Advances in AI and computer vision technology are making this possible."
In early February, Healthy.io raised $18 million in a Series B financing round led by Aleph, an Israeli-based venture capital fund, to support growth across its existing markets and to fund the commercial launch of the product in the United States. It also has raised funds from Samsung NEXT and private investors. That brings its total funding to $30 million.
Healthy.io's products are currently available in Israel and the U.K., where it recently inked a deal with Walgreens Boots Alliance subsidiary Boots UK to introduce consumer-focused UTI testing at the company's locations. Its efforts have been supported by a partnership with Siemens Healthineers to use the company's urinalysis reagents.
The start-up is boosted by rapidly advancing smartphone technology. Digital urinalysis is the latest example of a trend toward home diagnostics driving a surging medical technology market. The first at-home pregnancy test appeared in the late 1970s, paving the way for a home-based medical test market. More recently, the internet, IoT, smartphones and advances in areas like genetic testing have driven sharp growth in a home-testing market that will soon surpass $300 million.
Much of the marketing driving sales of at-home tests, which include cloud-based monitors that beam medical results to doctors, tout ease of use and lowered barriers to clinical-grade health maintenance. But getting people to take tests, whether in a doctor's office or at home, is tricky. In the case of kidney disease, which the Healthy.io kit can screen for, only about 6 percent of people with hypertension and 39 percent of diabetes patients undergo proper testing.
It's still too early to know if Healthy.io's technology will be a game-changer in kidney testing, but if it does, it could have a big impact on curbing health-care costs — and saving lives. "The FDA is now approving clinical algorithms and outcomes derived by using a cellphone for urine testing. That's a big step in helping to democratize health care," said Michael Eisenberg, a partner at Aleph.